Post-radiation Prostate Cancer Local Recurrences: Detection With Histoscanning™ and MRI

Prostate Cancer Recurrent Clinical Trial

— HISTO-RAD  

Official title:

Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857037
• Other study ID #: 2010.655
• Status: Completed
• Phase: N/A
• First received: March 28, 2012
• Last updated: February 26, 2015
• Start date: May 2011
• Est. completion date: August 2014

Study information

• Verified date: April 2011
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Inclusion criteria:

• Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR

• Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)

Study Design:

• Included patients will undergo an endorectal US examination with a Histoscanning™ acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic contrast-enhanced) MRI.

• Two independent operators will separately define suspicious focal lesion on Histoscanning™ images and on MR images.

• Random biopsies (at least 2 cores) will be performed in sextants negative at Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI, targeted biopsies will be performed in the suspicious part of the sextant (at least two cores per suspicious lesion).

• Histoscanning™ and MRI results will be compared to biopsy results.

A total of 30 patients will be included

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)

• IRB-approved informed consent signed

Exclusion Criteria:

• Contraindication to MRI

• Contraindication to endorectal examination

• Contraindication to prostate biopsy

• History of allergy to gadolinium chelates

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer Recurrent
• Prostatic Neoplasms

Intervention

Other:
• Histoscanning™ and multiparametric MRI
Detection and localization of prostate cancer local recurrences after radiation therapy using Histoscanning™ and multiparametric MRI

Locations

Country	Name	City	State
France	Prof O. ROUVIERE	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Histoscanning™ after radiation therapy in comparison to random and targeted biopsy.	Histoscanning and biopsy findings will be compared on a sextant by sextant basis. A mixed effects logistic regression model (with fixed and random effects) will be used to model the sensitivity and specificity of Histoscanning to correctly identify the presence or absence of cancer into prostate sextants.	1 day	No
Secondary	Evaluation of multiparametric MRI after radiation therapy in comparison to random and targeted biopsy.	MRI and biopsy findings will be compared on a sextant by sextant basis. A mixed effects logistic regression model (with fixed and random effects) will be used to model the sensitivity and specificity of MRI to correctly identify the presence or absence of cancer into prostate sextants.	1 day	No